Advisors to the US Food and Drug Administration have recommended giving the green light to Stallergenes and its grass pollen allergy treatment Oralair.
The agency's Allergenic Products Advisory Committee (APAC) voted that the available data support approval of Oralair for the treatment of grass pollen-induced allergic rhinitis or conjunctivitis in patients aged 10 and older. Oralair is a five-grass pollen extract immunotherapy sublingual tablet that has been marketed in Europe since 2008.
The five grass pollens included in Oralair - Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass - represent those to which most patients in the USA are exposed. Chief executive Roberto Gradnik believes the tablet "will bring a true benefit to US patients suffering from grass pollen induced allergy".
If approved, Oralair will be marketed by Greer Laboratories which linked up with Stallergenes at the end of October. The French company will be responsible for tablet production and supply.
The APAC will meet later today to review Merck & Co/ALK-Abello's grass allergy immunotherapy Grastek.